Responsible for R&D, Quality and Regulatory Affairs functionsEstablished an R&D office siteRecruited and restructuredRemoved ambiguity and applied focus to key business deliverablesResolved technical issues and moved instrumentation challenges forward rapidlyDrove needs and agenda for surgeon team engagementProduced planning, budgeting and forecasting.

Transformed a dysfunctional and overloaded team of 4 into a performing, motivated and up-skilled team of 10 through the most disruptive period of business in living memory thanks to COVID. Delivered a challenging new minimal access port system, established a compliant Design Control QMS process increased project management diligence and manufacturing support.

Grew team from 3 to 8 justified via capability vs. reduction in contractor spend. Recruited high calibre candidates into newly modelled roles. Product pipeline and departmental budget responsibility. Design Control authority and all product technical oversight responsibility for Class I to III implantable medical devices.Led strategy for Design Control impact of Medical Device Regulations and ISO 13485:2016, driving wider compliance activities and creating processes to comply with 13485, 21 CFR Part 820: 510k and DHF needs.Instigated adoption of ISO 14971:2012 in the company’s Risk Management process.• Created Clinical function to address key aspects of the Medical Device Regulations such as:o Chapter VI Clinical Evaluation and Clinical Investigationo Annex XIII Clinical Evaluation and Post-Market Clinical Follow-Up o Annex XIV Clinical Investigationsand also ISO 10993 (Biological evaluation of medical devices) looking towards ISO 14155:2011 (Clinical investigation), substantial equivalency arguments and other compliance gaps• Delivered Work Instruction for legacy product DHF remediation. Produced 2-year strategy for completion based on business risk and value, clinical history, traceability and risk• Introduced user needs work and outcome driven innovation into product development. Managed creation of design inputs and link through traceability into design validation activities• Led development of acetabular system with Ti alloy H.A. primary cup and CoCr dual mobility options. Lead inventor on patent 1518632.3 for concept in acetabular revision.• Pioneered electron beam additive manufacture for JRI. Assessed validation, cleaning, risk and manufacturing process. Developed trabecular structure, unit cell size, porosity and novel augment design.• Introduced Competency Modelling to JRI and a framework for role descriptions, recruitment and people development – key to Investors In People Gold award in 2015. Trained the exec and other key colleagues.

Led a team of 4 reports over a wider team of 15, including Senior Project Managers and Design Manager• Managed up to 15 projects to deliver on time, cost and specification to given CAPEX and P&L budgets.• Improved quality/output from design via upskilled engineering, more diligent process, FMEA and detail design. Regular cost saving, rationalisation and design for manufacture of all electro mechanical products.• Produced 5-year strategy featuring product roadmap, timings, people resourcing, supplier development.

• Provided management service of multiple R&D projects simultaneously at different stages of development. Successfully managed specialists and support services across different continents in one project team.• Established and maintained business objectives. Analysed, quantified and mitigated project risk.

A board position with responsibility for Design, Production Engineering, and Product Management. Managed 8 direct reports over 35 staff and budget of circa £2m across 3 UK sites. • Achieved the first Innovation Grant from parent company, Masco Inc., £431k for development of Inclusive Design: to involve research study to identify unmet user needs, generate concepts, select and develop them. • Succeeded in uniting and developing a divided team by reorganising into 3 departments, identifying and promoting key talent and implementing tailored programmes of review, learning & development. • Ran successful recruitment programme using core competency models and assessment centre, recruiting high calibre staff who produced designs with multiple design registrations and patents pending.• Achieved operating budget reduction from £2.75m for 2008 to £2.26m FYF in 2008 via completion of a site closure and redundancies. Further reduced spend to £2.06m actual, via additional cost savings.• Designed and implemented a process of product lifecycle management to promote strategic decision-making and connect sales & marketing via Product Management to NPD.

Undertook a variety of projects progressing to a varied international role fully responsible for R&D projects with accountability for project management, bioengineering, design & market implementation.• Established a reputation with worldwide VP Regulatory for the highest standard of regulatory submission throughout DePuy International, achieving maximum right-first-time regulatory certification.• Successfully delivered Memory Posterior Deformity System (nitinol shape memory alloy spinal rod system), and managed change hence. Created and drove plan while managing risk. Created, identified, registered and utilised I.P. to innovate and overcome competitor patents. • Launched Minimal Access Cage system. Managed international teams remotely, to deliver on time. Successfully led development of patented implants, instruments and surgical technique. Collaborated with marketing team to develop all marketing aspects.• The leading innovator and implementer (by quantity of projects completed and patent authoring) for development in spinal medical devices for Johnson & Johnson in the EMEA region.• Developed and maintained international relationships with key surgeons within public and private sectors.• Liaised with local sales & marketing teams in the J&J franchise to facilitate NPI to markets. Trained surgeons, theatre staff and sterilisation departments in the implementation of product and process.

Progressed quickly to be responsible for overall electro-mechanical design and implementation on major projects• Led team to launch cylinder vacuum cleaner on time, budget and to a brief involving management of design engineering from concept. Delegated tasks, supervised and developed skills of more junior engineers.• As Senior Design Engineer, acted as troubleshooter to varied projects, bringing skills and experience to teams during high-pressure phases. Managed critical design paths and ensured cohesion of product design. Regularly interacted with Sir James Dyson.• Managed expert 3D CAD model problem solving and assemblies for major projects, each involving around 150+ components of up to 2500 features each, advising individual engineers working on child parts.• Delivered rapid prototyping involving workshop and contract modelling, FDM, SLA, PU resin vacuum casting, machining, assembly, paint, finish and testing. Proved production capability via pre-production builds.• Achieved BOM cost reduction of 10% via cost reduction initiatives.• Year placement as Tooling Engineer: an on-call role of intense experience. Managed new, and modification of current injection mould tooling. Developed tool G.A.s, planning and budgeting, selection of materials and components, management of toolmakers and moulders, trialling and approval. Successfully delivered modifications and repairs of all types under pressure.• Spent a month in Taiwan troubleshooting new suites of injection mould tooling.• Significant travel to/in Portugal on major injection mould tooling project, involving supervision of tool trials, assessment of samples, tool development and supplier management.

• Styling concept generation, presentation, review, detail development and engineering change to tight deadlines for Aston Martin, Leyland Daf Vans, Saab, British Gas and Rover.

• Commissioned officer, studying Mechanical Engineering at Cranfield University (with scholarship).• Successfully selected via RAF Biggin Hill officer selection, twice.• Successfully executed junior officer role in several field exercises, developing team management, communication and leadership skills.